E Gil Berglund

TL;DR: Recent instances of the use of PBPK in decision‐making during regulatory review are reviewed, based on Center for Drug Evaluation and Research reviews of several submissions for investigational new drugs and new drug applications received between July 2008 and June 2010.

TL;DR: The International Transporter Consortium organized a second workshop in March 2012 to expand on the themes developed during the inaugural ITC workshop held in 2008, and focused primarily on the decision trees published from the first workshop.

TL;DR: The use and impact ofPhysiologically based pharmacokinetic modeling in selected regulatory procedures submitted to the European Medicines Agency before the end of 2015, together with its subsequent reflection in public documents relating to the assessment of these procedures, are reviewed.

TL;DR: The question remains whether the efficacy of amodiaquine is affected by the gene polymorphism, and the possible relevance, or lack of, of CYP2C8 polymorphisms in the present and future efficacy of the drug is reviewed.

TL;DR: The effects of GH on codeine clearance and two enzymes of the cytochrome P450 (CYP) family, CYP3A and CYP2D6, and UDP‐glucuronosyl transferase (UDPGT), which have a superior importance in hepatic biotransformation of numerous drugs are investigated.